MammaPrint's FDA Indication – Patient Eligibility in the USA

Breast cancer recurrence and/or metastasis is partly dependent on the activation and suppression of certain genes located within the primary breast tumor.  MammaPrint is a genomics test which uses the latest microarray technology to analyze a patient's breast tumor biology to predict whether existing cancer has the wherewithal to metastasize. This 70-gene profile is validated as an independent indicator for breast cancer prognosis for women with lymph node-negative, estrogen receptor positive and estrogen receptor negative disease.

To be eligible for the MammaPrint gene expression profile, a breast cancer patient should fulfill the following criteria:

• Breast Cancer Stage 1 or Stage 2
• Invasive carcinoma (infiltrating carcinoma)
• Tumor size <5.0 cm
• Lymph node negative
• Estrogen receptor positive (ER+) or Estrogen receptor negative (ER-)
• Women of all ages

MammaPrint provides powerful insights into a patient's breast cancer risk of recurrence and need for adjuvant therapy.  When making breast cancer treatment decisions for your patients, regarding hormone therapy (Tamoxifen) alone or in conjunction with chemotherapy, it is important to consider a woman's clinical and pathology related risk factors to determine the best treatment plan and potential response to systemic adjuvant therapy.